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Food and Drug Administration, HHS.
The Food and Drug Administration (FDA) is announcing a publication containing modifications the agency is making to the list of standards FDA will recognize for use in premarket reviews (FDA Recognized Consensus Standards). This publication entitled “Modifications to the List of Recognized Standards, Recognition List Number: 005” (Recognition List Number: 005) will assist manufacturers who elect to declare conformity with consensus standards to meet certain requirements for medical devices.
Submit written comments concerning this document at any time. See section VI of this document for the effective date of the recognition of standards announced in this document.
Submit written requests for single copies on a 3.5′′ diskette of “Modification to the List of Recognized Standards, Recognition List Number: 005,” to the Division of Small Manufacturers Assistance, Center for Devices and Radiological Health (HFZ-220), Food and Drug Administration, 1350 Piccard Dr., Rockville, MD 20850. Send two self-addressed adhesive labels to assist that office in processing your requests, or fax your request to 301-443-8818. Submit written comments concerning this document to the contact person (address below). Comments should be identified with the docket number found in brackets in the heading of this document. This document may also be accessed on FDA's Internet site at http://www.fda.gov/cdrh/fedregin.html. See section V of this document for electronic access to the searchable database for the current list of “FDA Recognized Consensus Standards,” including Recognition List Number: 005 modifications, and other standards related information.Start Further Info
FOR FURTHER INFORMATION CONTACT:
To comment on this document and/or to recommend additional standards for recognition: Carol L. Herman, Center for Devices and Radiological Health (HFZ-84), Food and Drug Administration, 2094 Gaither Rd., Rockville, MD 20850, 301-594-4766, ext. 156.End Further Info End Preamble Start Supplemental Information
Section 204 of the Food and Drug Administration Modernization Act of 1997 (FDAMA) (Public Law 105-115) amended section 514 of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 360d). Amended section 514 allows FDA to recognize consensus standards, developed by international and national organizations, for use in satisfying portions of device premarket review submissions or other requirements.
In a notice published in the Federal Register of February 25, 1998 (63 FR 9561), FDA announced the availability of the guidance entitled “Recognition and Use of Consensus Standards.” This notice described how FDA will implement its standards program recognizing the use of certain standards and provided the initial list of recognized standards.
In Federal Register notices published on October 16, 1998 (63 FR 55617), July 12, 1999 (64 FR 37546), and November 15, 2000 (65 FR 69022), FDA modified its initial list of recognized standards. These notices described the addition, withdrawal, and revision of certain standards recognized by FDA. When these notices were published, the agency maintained “html” and “pdf” versions of the list of “FDA Recognized Consensus Standards.” Both versions were publicly accessible at the agency's Internet site. The agency maintains the current list in a searchable database accessible to the public. See section V of this document for electronic access information.
II. Discussion of Modifications to the List of Recognized Standards, Recognition List Number: 005
FDA is announcing the addition, withdrawal, correction, and revision of certain consensus standards the agency will recognize for use in satisfying premarket reviews for devices. FDA will incorporate these modifications in the list of “FDA Recognized Consensus Standards” in the agency's searchable database. FDA will use the term “Recognition List Number: 005” to identify: (1) Supplementary information sheets for standards added to the list for the first time, (2) standards added to replace withdrawn standards, and (3) still recognized standards for which minor revisions are made to clarify the application of the standards.
At the end of this notice, FDA lists modifications the agency is making that involve: (1) The initial addition of standards not previously recognized by FDA and (2) the addition of standards in conjunction with the withdrawal of other standards that are replaced by these later, amended, or different standards.
In this section, FDA describes modifications that involve the withdrawal of standards and their replacement by others. In this notice, all changes of this type are in the sterility category of the complete list of recognized standards.
1. ASTM-F1140:1996 is withdrawn under previous item 59. ASTM-F1140:2000 is added under current item 67.
2. ASTM-F1585:1995 is withdrawn under previous item 61. ASTM F1585:2000 is added under current item 68.
3. ASTM-1608:1995 is withdrawn under previous item 62. ASTM F1608:2000 is added under current item 69.
III. List of Recognized Standards
FDA maintains the agency's current list of “FDA Recognized Consensus Standards” in a searchable database that may be accessed directly at FDA's Intranet site at http://Start Printed Page 23033www.acessdata.fda.gov/scripts/cdrh/cfdocs/cfStandards/search.cfm. FDA will incorporate the modifications and minor revisions described in this notice into the database and, upon publication in the Federal Register, this recognition of consensus standards will be effective.
FDA will announce additional modifications and minor revisions to the list of recognized consensus standards, as needed, in the Federal Register once a year, or more often, if necessary.
IV. Recommendation of Standards for Recognition by FDA
Any person may recommend consensus standards as candidates for recognition under the new provision of section 514 of the act by submitting such recommendations, with reasons for the recommendation, to the contact person (address above). To be properly considered, such recommendations should contain, at a minimum, the following information: (1) Title of standards, (2) any reference number and date, (3) name and address of the national or international standards development organization, (4) a proposed list of devices for which a declaration of conformity to this standard should routinely apply, and (5) a brief identification of the testing or performance or other characteristics of the device(s) that would be addressed by a declaration of conformity.
V. Electronic Access
In order to receive “Guidance on the Recognition and Use of Consensus Standards” via your fax machine, call the CDRH Facts-On-Demand system at 800-899-0381 or 301-827-0111 from a touch-tone telephone. Press 1 to enter the system. At the second voice prompt press 1 to order a document. Enter the document number 321 followed by the pound sign (#). Follow the remaining voice prompts to complete your request.
Persons interested in obtaining a copy of “Guidance on the Recognition and Use of Consensus Standards” may also do so by using the Internet. CDRH maintains a site on the Internet for easy access to information including text, graphics, and files that may be downloaded to a personal computer with access to the Internet. Updated on a regular basis, the CDRH home page includes this guidance as well as the current list of recognized standards and other standards related documents. After publication in the Federal Register, this notice announcing “Modifications to the List of Recognized Standards, Recognition List Number: 005” will be available on the CDRH home page. The CDRH home page may be accessed at http://www.fda.gov/cdrh. The “Guidance on the Recognition and Use of Consensus Standards,” and the searchable database for “FDA Recognized Consensus Standards,” may be accessed through hyper links at http://www.fda.gov/cdrh/stdsprog.html. This Federal Register notice of modifications in FDA's recognition of consensus standards will be available, upon publication, at http://www.fda.gov/cdrh/fedregin.html.
VI. Submission of Comments and Effective Date
Interested persons may, at any time, submit to the contact person (address above) written comments regarding this document. Two copies of any comments are to be submitted, except that individuals may submit one copy. Comments are to be identified with the docket number found in brackets in the heading of this document. Received comments will be considered in determining whether to amend the current listing of “Modifications to the List of Recognized Standards, Recognition List Number: 005.”
The recognition of standards announced in this notice of modifications will become effective on May 7, 2001.
VII. Listing of New Entries
The listing of new entries and consensus standards added as “Modifications to the List of Recognized Standards,” under Recognition List Number: 005, is as follows:
|Item Number||Title of Standards||Reference Number and Date|
|34||Standard Test Method for Evaluation the Ignition Sensitivity and Fault Tolerance of Oxygen Regulators Used for Medical and Emergency Applications||ASTM PS127:2000|
|31||Standard Practice for Evaluating and Specifying Implantable Shunt Assemblies for Neurosurgical Applications||ASTM F647-94|
|32||Standard Specification for the Requirements and Disclosure of Self-Closing Aneurysm Clips||ASTM F1542-94 (2000)|
|33||Neurosurgical Implants-Sterile, Single-Use Hydrocephalus Shunts and Components||ISO 7197:1997|
|25||Standard for the Development of an Electrostatic Discharge Control Program||ANSI/ESD S20.20-1999|
|26||Medical Devices-Application of Risk Management to Medical Devices||ISO 14971:2000|
|67||Standard Test Methods for Internal Pressurization Failure Resistance of Unrestrained Packages for Medical Applications||ASTM F1140:2000|
|68||Standard Guide for Integrity Testing of Porous Barrier Medical Packages||ASTM F1585:2000|
|69||Standard Test Method for Microbial Ranking of Porous Packaging Materials (Exposure Chamber Method)||ASTM F1608:2000|
Dated: April 24, 2001.
David W. Feigal, Jr.,
Director, Center for Devices and Radiological Health.
[FR Doc. 01-11329 Filed 5-4-01; 8:45 am]
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